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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008060 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil combined with leucovorin and either irinotecan or oxaliplatin in treating patients who have unresectable metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Fluorouracil, Oxaliplatin and Irinotecan: Use and Sequencing: A Randomized Trial to Assess the Role of Irinotecan and Oxaliplatin in Advanced Colorectal Cancer |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of five treatment arms.
Quality of life is assessed at baseline, at weeks 6 and 12, and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 2,100 patients (700 in arm I and 350 each in arms II-V) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Medical Research Council Clinical Trials Unit | |
London, England, United Kingdom, NW1 2DA |
Study Chair: | Matthew T. Seymour, MA, MD, FRCP | Medical Research Council |
Study ID Numbers: | CDR0000068372, MRC-CR08-FOCUS, EU-20038, ISRCTN79877428 |
Study First Received: | January 6, 2001 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00008060 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Rectal Diseases Oxaliplatin Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Rectal Neoplasm |
Trace Elements Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Camptothecin Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |